Visi-Pro PXB35-07-37-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036433), received between Mar 21, 2018 and Apr 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K061566); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN USED A VISIPRO DEVICE WITH A 6FR SHEATH AND 0.035 GUIDEWIRE FOR THE TREATMENT OF A CALCIFIED LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE AORTA WAS REPORTED TO BE TORTUOUS. ACCESS WAS IN THE LEFT AUXILLARY ARTERY. THE LESION EXHIBITED SEVERE ATHEROSCLEROSIS. SEVERE OCCLUSION WAS REPORTED IN THE RIGHT COMMON ARTERY. NO DAMAGE WAS NOTED TO PACKAGE. THE DEVICE WAS PREPARED PER IFU WITH NO ISSUES NOTED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND A 5X100 EVERCROSS BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: HIV, Human Immunodeficiency Virus

  MAUDE report 7435841 ↗
• MalfunctionMar 21, 2018Inaccurate Delivery; Inaccurate Delivery

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISIPRO BALLOON EXPANDABLE STENT TO TREAT A SOFT TISSUE LESION IN THE RIGHT DISTAL COMMON ILIAC ARTERY. THE LESION WAS NOT CALCIFIED, HAD NO STENOSIS AND WAS NOT TORTUOUS. THE ARTERY DIAMETER WAS 7-8MM. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS NOT PRE-DILATED AND NO EXCESSIVE FORCE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS SUFFICIENT DISTAL LANDING ZONE. DURING THE ADVANCEMENT OF THE DEVICE TO THE INTENDED LESION SITE THE PROXIMAL PORTION OF THE STENT DEPLOYED, THE VISIPRO WAS INFLATED AND DEPLOYED IN THE EXTERNAL ILIAC ARTERY. NO ATTEMPTS WERE MADE TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BALLOON EXPANDABLE STENTS DEPLOYED TO BILATERAL COMMON ILIAC STENTS SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061566. One submission often covers many models, so check the product and lot details in each record.

• Z-1548-2008 · Jul 1, 2008 · Terminated
  ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27
• Z-1547-2008 · Jul 1, 2008 · Terminated
  ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PX